The invention is related generally to connectors of the type used in the handling and administration of medical fluids, and more particularly, to vial adapters useful for the rapid reconstitution and withdrawal of medicament from vials.
Access ports for injecting fluid into or removing fluid from a system, such as a drug vial, are well known and widely used. Conventional injection sites in drug vials generally involve a pierceable rubber stopper formed of an elastomeric material such as butyl rubber or the like, placed in the opening of the vial. A closure, typically formed of metal, is crimped over the rubber stopper and the flange of the vial to positively hold the stopper in place in the opening of the vial. The closure has an outer size, known as a “finish size.” The closure also has an opening, or access port, through which the stopper and the vial opening may be accessed. A sharp cannula is inserted into the access port piercing the rubber stopper to position the distal, open end of the cannula past the rubber stopper to make fluid connection with the interior of the vial. In the case of certain medications, such as those used for chemotherapy or nuclear medicine, the rubber stopper is made thicker so that increased protection is provided against leakage.
Adapters have been found useful in that they can adapt the sharpened cannula that is placed into fluid communication with the vial to the connection device of another fluid container or fluid conduction device. For example, the adapter may include a female Luer fitting opposite the sharpened cannula to receive the nozzle of a syringe. The “adapter” therefore adapts the vial to the syringe, or adapts the sharpened cannula to the Luer-shaped nozzle of the syringe.
It has also been found useful in some applications to provide a means to attach or anchor the adapter to the vial to hold it in place while fluid communication between the vial and another device proceeds so that inadvertent disengagement of the adapter from the vial does not occur. For example, the adapter may have arms that engage the neck or flange of the vial and hold the adapter in place on the vial. Other means include a shroud that fits around the outside of the vial closure and snaps onto the vial closure under the crimped retaining cap thereby grasping the vial neck flange and the underside of the closure.
It has also been found useful in some applications to have a valve placed in the adapter to result in a closed system. The valved adapter permits engagement of the sharpened cannula with the contents of the vial without leakage of fluid from the vial through the adapter. Then when the second fluid device has been prepared, it can be connected to the adapter thereby activating the valve that then permits fluid flow between the vial and second fluid device.
Vials made of glass or polymeric materials, the walls of which are non-collapsible, require an air inlet when medical fluid is withdrawn therefrom to prevent the formation of a partial vacuum therein. Typically, vials containing a medical fluid are closed by rubber stoppers which are pierced by a spike having both a medicament fluid lumen and a vent lumen therein. The vent lumen may contain a filter to prevent the entry of particulate matter or bacteria into the vial during the medicament withdrawal process. Another purpose of the filter may include the prevention of venting to the outside atmosphere any atomized medicament or aerosols that are formed within the vial during the reconstitution process.
Many medicaments are prepared, stored, and supplied in dry or lyophilized form. Such medicaments must be reconstituted at the time of use by the addition of a diluent thereto. Various methods of adding the diluent to the dry or lyophilized medicament have been used over the years. One method that is commonly used is the vial adapter technique in which the diluent that may be contained in a bottle or a syringe is connected to the vial adapter which has a sharpened cannula. Once connected to the diluent, the sharpened cannula is then forced through the rubber septum closure of the vial to communicate the diluent to the dry or lyophilized medicament in the vial. After reconstitution, the liquid is usually returned to the intravenous solution bottle or syringe, or other container for administration to the patient through an intravenous (“IV”) administration set. With some vial adapters, this technique is unsatisfactory because both the dry or lyophilized material and the diluent can be exposed to ambient airborne bacterial contamination if a filter is not present in the vial adapter.
During the reconstitution process, it is desirable to avoid contamination of the surrounding air through formation of aerosols or drops. This is possible during the injection of the diluent into the vial. This air contamination can lead to problems among other things in the form of allergic reactions in the exposed personnel, especially when it is a question of cytotoxic drugs, chemotherapeutic drugs, anesthetics, media containing isotopes, and allergy inducing substances of various kinds.
It would be desirable to provide a vented vial adapter for use with non-collapsible containers that is designed to prevent aerosolizing of liquid material as reconstitution occurs. It is desirable for the person performing the procedures to avoid contacting the medications, especially the inhalation of aerosolized medications. A vial adapter with sufficient venting and filtering is necessary to avoid such aerosolizing.
It is also desirable to provide a vial adapter that enables the rapid withdrawal of reconstituted medication from a vial. Clinicians are extremely busy people and systems and devices that can safely speed up the medication administration processes are desirable. Once reconstituted, it is desirable to withdraw the medicament from the vial as rapidly as possible so that administration to the patient can proceed. However, it the venting of the vial does not have the same or better flow capacity than the withdrawal flow rate of the reconstituted medicament by the syringe, air bubbles may be drawn into the syringe with the medicament. This is because a relatively high partial vacuum level may be created inside the vial due to inadequate venting. This high level of partial vacuum then can cause any air that is introduced to the vial to be drawn immediately into the syringe, instead of remaining in the vial. While patients can tolerate receiving a certain level of air from an IV medical fluid line, too high of a level of air can result in an air embolism with an adverse effect on the patient. Hence, a sufficient vial venting system is desirable.
Some manufacturers have attempted to create larger venting systems in vial adapters having sharpened cannulae. As an example, a venting lumen through the sharpened cannula and the body of the adapter has been formed so that the flow of venting air into the vial is equal to or greater than the flow of reconstituted medicament out of the vial. However in at least one manufacturer's system, the sharpened cannula had such a large outer diameter to accommodate the enlarged vent lumen that it became difficult to force such a large cannula through the rubber septum of a vial. It was even more difficult to force through the thickened stopper of a vial containing a chemotherapy medication. Increased strength is needed on the part of the clinician to pierce the septum, which is also undesirable. In this prior design and in others, reducing the diameter of the sharpened cannula while retaining the enlarged size of the vent lumen would result in a weakened cannula that can fracture or break off during the process of piercing the vial's stopper.
Hence, those skilled in the art have recognized a need for a vial adapter having improved venting capability while at the same time providing a sharpened cannula that remains as small as possible yet has enough strength to pierce a vial septum without breaking or fracturing. The present invention fulfills these needs and others.